Идёт набор NCT05951088

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)

— Наблюдательное Follow-up Education Mobile Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cardio2U follow-up.
Кому может быть актуально: Состояния в реестре: Follow-up, Education, Mobile Health. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients

Обзор

This trial has to aim to evaluate an innovative, in-house developed mobile application supporting patients in their home environment by actively involving them in different aspects of their condition and treatment. The usability, long-term adherence and patient satisfaction will be studied in patients with atrial fibrillation (AF) and/or heart failure (HF).

Подробное описание

Atrial fibrillation (AF) and heart failure (HF) are global cardiovascular disease epidemics associated with significant morbidity and mortality. Their prevalence is already high and will continue to increase in the coming decades. A structured and efficient care system encompassing various aspects is needed to manage AF and HF morbidity and mortality. Technological developments and the increased use of smart devices, including in medical care, create opportunities to implement mobile applications to provide continuous, high-quality follow-up to patients. Our in-house developed application, recently improved and expended, provides a reliable source of educational material on AF and HF, with the ability to save health appointments, enter measurements (such as heart rate, blood pressure, weight) and keep a medication list (including notifications when medication should be taken). In addition, the application includes questionnaires to assess, for example, patients' knowledge, selfcare, quality of life, physical activity and symptoms. The application allows personalisation per patient depending on the clinical setting and indication. The innovative application will be evaluated in terms of usability, long-term adherence and patient satisfaction.

Вмешательства

Процедура Cardio2U follow-up
During the follow-up period, participants will have access to the application and will be able to explore the different modules. At fixed time points, the application will allow them to fill in questionnaires about the application's usability and patient satisfaction. App user data will track how long and how often patients visit the application and which aspects are mostly used. In addition, at different time points during the study, patients will be asked to complete clinical questionnaires re

Первичные конечные точки

Usability of the application [Срок оценки: Change of usabilitiy of the application from baseline to12 months]
Patient satisfaction with the application-driven follow-up [Срок оценки: Change from baseline patient satisfaction with the application to 3- and 12 months]
Long-term adherence [Срок оценки: From date of randomization until end of study, assessed up to 36 months]

Вторичные конечные точки (2)

Disease specific Knowledge [Срок оценки: Change from baseline to 1, 3, 6, and 12 months]
Disease specific self-care management [Срок оценки: Change from baseline to 3 and 12 months]

Критерии участия

Критерии включения

Age ≥ 18 years,
Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, Holter monitor,…) and/or patients in whom HF is diagnosed in their medical records,
Patients who are capable of signing the informed consent.